Efficacy and Safety Study of Nexagon for Persistent Corneal Epithelial Defects (NCT01165450) | Clinical Trial Compass
TerminatedPhase 2
Efficacy and Safety Study of Nexagon for Persistent Corneal Epithelial Defects
Stopped: Drug manufacturer could not supply study drug.
2 participantsStarted 2011-11
Plain-language summary
The purpose of this study is to evaluate the efficacy and safety of Nexagon® in subjects with persistent corneal epithelial defects (PED) resulting from corneal epithelial debridement during diabetic vitrectomy surgery, HSV keratitis, HZV keratitis, corneal burns, post-PRK, or post-corneal transplant surgery.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Male and female subjects aged 18 years and over.
* Female subjects must be a) postmenopausal, b) surgically sterilized, c) practicing abstinence, or d) using a hormonal contraceptive, intrauterine device, diaphragm with spermicide, or condom with spermicide for the duration of the study.
* Subjects who are able to attend all follow-up visits and who are able to comply with all study procedures.
* Subjects who are willing and able to give written informed consent to take part in the study.
* Subjects with a PED, defined as follows: "a corneal epithelial defect persisting for at least 14 days and not longer than 28 days."
* In the Investigator's opinion, the defect is persistent i.e., the defect has not shown improvement despite conventional treatment such as tear supplements and bandage contact lenses.
* The original defect to the cornea must have resulted from corneal epithelial debridement during diabetic vitrectomy surgery, HSV keratitis, HZV keratitis, corneal burns, post-PRK, or post-corneal transplant surgery.
Exclusion Criteria:
* Use of concomitant ocular medications in the screening period that are not specified in standardized PED treatment regimen
* Likely to require the use of concomitant ocular medications that are not specified in the standardized PED treatment regime during the study follow-up period
* Decrease or increase in the PED by more than 50% during the screening period.
* Have an active eyelid or ocular infectious process of any…
What they're measuring
1
Percent Healing of the Corneal Epithelial Defect at Day 14 ± 1 in the Study Eye
Timeframe: 14 ± 1 days
2
Incidence of Adverse Events Following Application of the Investigational Product in All Subjects